BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4133277 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31477
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE A LOOSE AND PROTRUDED DRIVE SUPPORT DISK. NO ALARM WAS NOTED FOR THE LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, A BROKEN BELT CLIP SLOT, A CRACKED RESERVOIR TUBE LIP AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED DURING PRIME. BLOOD GLUCOSE VALUE IS 189 MG/DL. IT WAS STATED THAT THE PISTON CONTINUE TO MOVE FORWARD AFTER RESERVOIR CONTACT AND INSULIN SQUIRED OUT. IT WAS REPORTED THAT NO NUMBERS APPEARED ON SCREEN AND NO BEEPS HEARD. CUSTOMER TRIED WITH DIFFERENT SETS AND WAS UNABLE TO PRIME. NO DAMAGE OF THE DRIVE SUPPORT CAP NOTED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610831 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWP

    Patients

    Seq Age Sex Outcome Treatment
    1